{"product_id":"fda-510k-k180513","title":"FDA 510(k) K180513, CustomizedBone Service, by Fin-Ceramica Faenza S.P.A.","description":"\u003cp\u003e\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003ePlate, Cranioplasty, Preformed, Non-Alterable\u003cbr\u003e\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK180513\u003cbr\u003e\u003cstrong\u003eDevice Name:\u003c\/strong\u003e CustomizedBone Service\u003cbr\u003e\u003cstrong\u003eApplicant:\u003c\/strong\u003e Fin-Ceramica Faenza S.P.A.\u003cbr\u003e\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e882.533\u003cbr\u003e\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eGXN\u003cbr\u003e\u003cstrong\u003eDate Received: \u003c\/strong\u003e02\/27\/2018\u003cbr\u003e\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 05\/15\/2018\u003cbr\u003e\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eNeurology\u003cbr\u003e\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eNeurology\u003cbr\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 669\u003cbr\u003e\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 384\u003cbr\u003e\u003cstrong\u003eContent pages:\u003c\/strong\u003e 285\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51308059099300,"sku":"FDA510K180513","price":857.04,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k180513","provider":"FOIA Document Source","version":"1.0","type":"link"}